Celecoxib 200 Mg Capsule Hard
* A delayed allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen glands, and abnormal test results (e.g,, liver, blood cell (eosinophilia, a type of raised white blood cell count)).
In clinical studies not associated with Arthritis or other arthritic conditions, where Celecoxib was taken at doses of 400mg per day for up to 3 years, the following additional side effects have been observed
Common
* Heart problems! angina (chest pain)
* Stomach problems! irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion, wind)
* Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine
* Weight gain.
Uncommon
* Deep vein thrombosis (blood clot usually in the leg, which may cause pain, swelling or redness of the calf or breathing problems)
* Stomach problems! stomach infection (which can cause irritation and ulcers of the stomach and intestines)
* Lower lim b fracture
* Shingles, skin infection, eczema (dry itchy rash), pneumonia (chest infection (possible cough, fever, difficulty breathing))
* Floaters in the eye causing blurred or impaired vision, vertigo due to inner ear troubles, sore, inflamed or bleeding gums, mouth sores
* Excessive urination at night, bleeding from piles/ haemorrhoids, frequent bowel movements
* F atty lumps in skin or elsewhere, ganglion cyst (harmless swellings on or around joints and tendons in the hand or foot), difficulty speaking, abnormal or very heavy bleeding from the vagina, breast pain
* High levels of sodium in blood test results.
Reporti ng of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website! www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
m
BROWN & BURK
Package leaflet: Information for the user
Celecoxib 100 mg, capsule, hard Celecoxib 200 mg, capsule, hard
Celecoxib
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
" If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
" If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
I hese capsules are available in multiple strengths but will be referred to as Celecoxib throughout this leaflet.
What is in this leaflet
1. What Celecoxib is and whatit is used for
2. Whatyou need to know before you take Celecoxib
3. How to take Celecoxib
4. Possible side effects
5. How to store Celecoxib
6. Contents of the pack and other information
1. What Celecoxib is and what it is used for
5. Howto store Celecoxib
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of thatm onth.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Celecoxib 100 mg and 200 mg capsules contains the active substance celecoxib. Celecoxib belongs to a group of medicinal products called non steroidal anti 'inflammatory drugs (NSAIDs), and specifically a sub" group known as (COX"2) inhibitors. Your body makes prostaglandins that may cause pain and inflammation. In conditions such as rheumatoid arthritis and osteoarthritis your body makes more of these. Celecoxib acts by reducing the production of prostaglandins, thereby reducing the pain and inflammation.
Celecoxib is used to treat symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
2. Whatyou need to know before you take Celecoxib
6. Contents of the pack and other information
What Celecoxib Capsules contain
The active substance is Celecoxib.
Each capsule contains either 100 mg or 200 mg Celecoxib.
The other ingredients are!
Capsule fill contains: L actose Monohydrate, Croscarmellose sodium, Povidone K"30, Sodium lauryl sulfate, Magnesium Stearate.
Capsule shell contains: T Itanium Dioxide E171 and Gelatin.
Printing ink contains: S hellac, Propylene glycol, Black iron oxide E172 and Potassium hydroxide.
What Celecoxib Capsules looks like and contents of the pack
elecoxib 100 mg, capsule, hard !
12'.
White opaque / White opaque, size 0 hard gelatin capsule printed with IVI on cap and I L on the body filled with white to off white granular powder.
elecoxib 200 mg, capsule, hard !
You have been prescribed Celecoxib by your doctor. The following information will help you get the best
results with Celecoxib. If you have any further questions please ask your doctor or pharmacist.
If your doctor has indicated that you have an intolerance to some sugars, contact your doctor before taking
this medicine.
Donottake Celecoxib
* if you are allergic (hypersensitive) to celecoxib or any of the other ingredients of Celecoxib capsules (See section 6).
* if you have had an allergic reaction to a group of medicines called sulphonamides (e.g. some antibiotics used to treat infections).
* if you currently have an ulcer in your stomach or intestines, or bleeding in your stomach or intestines.
* if you have had asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic" type reactions after taking acetyisalicyiic acid or NSAIDs including C0X"2 (cyclooxygenase "2) inhibitors.
* if you are pregnant. If you can become pregnant during ongoing treatment you should discuss methods of contraception with your doctor.
* if you are breasffeeding.
* if you have severe hepatic dysfunction (serum albumin <25g/l or Child"Pugh score > 1 0).
* if you have severe kidney disease (creatinine clearance <30 ml / min).
* if you have an inflammatory disease of the intestines such as ulcerative colitis or Crohn s disease.
* if you have Congestive heart failure (NYHAII-IV).
* if you have established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
13'.
White opaque / White opaque, size I hard gelatin capsule printed with IVI on cap and 10 on the body filled with white to off white granular powder.
Celecoxib Capsules are packaged in Clear PVC/PVdC/Aluminium foil blister pack cotaining 10,20,30,40,
50, 60, 1 00, 1 0x1 0, 1 0x30, 1 0x50, 1 x50 unit dose, 1 x1 00 unit dose, 5x(1 0x1 0) capsules.
Marketing Authorisation Holder and Manufacturer:
Brown & Burk UK Ltd 5, Marryat Close Hounslow West Middlesex
TW45DQ
United Kingdom
This medicinal product is authorised inthe Member States of the EEA under the following names:
PTC elecoxib Brown, 100 mg & 200 mg Capsula UK: Celecoxib 100 mg & 200 mg capsule, hard.
DE: Celecoxib"Micro Labs 100 mg & 200 mg Hartkapseln FR: Celecoxib Brown & Burk 1 00 mg & 200 mg, gelule
Warnings and precautions
I his leaflet was last approved in
December 2014
Artwork code
BBUK CODE
Talk to your doctor or pharmacist before using Celecoxib
* if you have previously had an ulcer or bleeding in your stomach or intestines. (Donottake Celecoxib if you currently have an ulcer or bleeding in your stomach or intestine).
if you are taking acetyisalicyiic acid (even at low dose for heart protective purposes) if you use medicines to reduce blood clotting (e.g. warfarin)
if you are using Celecoxib at the same time as other non"acetylsalicyiic NSAIDs such as ibuprofen or diclofenac. The use of these medicines together should be avoided if you smoke, have diabetes, raised blood pressure or raised cholesterol
if your heart, liver or kidneys are not working well your doctor may want to keep a regular check on you if you have fluid retention (such as swollen ankles and feet)
if you are dehydrated, for instance due to sickness, diarrhoea or the use of diuretics (used to treat excess fluid in the body)
if you have had a serious allergic reaction ora serious skin reaction to any medicines
if you feel ill due to an infection or think you have an infection, as Celecoxib may mask a fever or other signs of infection and inflammation
if you are over 65 years of age your doctor may want to keep a regular check on you
if you have hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose" galactose malabsorption
* if you are poor meta bolisers of CYP2C9.
As with other NSAIDs (e.g. ibuprofen or diclofenac) this medicine may lead to an increase in blood pressure, and so your doctor may ask to monitor your blood pressure on a regular basis.
Some cases of severe liver reactions, including severe liver inflammation, liver damage, liver failure (some with fatal outcome or requiring liver transplant), have been reported with celecoxib. Of the cases that reported time to onset, most severe liver reactions occurred within one month of start of treatment.
Celecoxib may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems to become pregnant (see section on Pregnancy and breast" feeding).
Children: C elecoxib is for adults only, it is not for use in children.
Other medicines and Celecoxib
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription!
Dextromethorphan (used to treat coughs)
inhibitors or angiotensin II antagonists ^u seel for high blood pressure and heart failure^
lure tics ^used to treat excess fluid in the bodyj Fluconazole and rifampicin (used to treat fungal and bacterial infections)
Warfarin or other oral anticoagulants (' blood "thinning agents that reduce blood clotting)
Lithium (used to treat some types of depression)
Other medicines to treat depression, sleep disorders, high blood pressure or an irregular heartbeat Neuroleptics (used to treat some mental disorders)
Methotrexate (used to treat rheumatoid arthritis, psoriasis and leukaemia)
Oarbamazepine (used to treat epilepsy/seizures and some forms of pain or depression)
Barbiturates (used to treat epilepsy/seizures and some sleep disorders)
Oiclosporin and tacrolimus (used for immune system suppression e.g. after transplants).
Celecoxib can be taken with low dose aspirin (75 mg or less daily). Ask your doctor for advice before taking both medicines together.
Celecoxib with food and drink
Celecoxib can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Celecoxib must not be used by women who are pregnant or can become pregnant (i.e. women of child bearing potential who are not using adequate contraception) during ongoing treatment. If you become pregnant during treatment with Celecoxib you should discontinue the treatment and contact your doctor for alternative treatment.
Celecoxib must not be used during breasffeeding.
Driving and using machines
You should be aware of how you react to Celecoxib before you drive or operate machinery. If you feel dizzy or drowsy after taking Celecoxib, do not drive or operate machinery until these effects wear off.
Important information about some of the ingredients of Celecoxib Capsules
Celecoxib Capsules contains lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HowtotakeCelecoxib
Always take Celecoxib exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If you think or feel that the effect of Celecoxib is too strong or too weak, talk to your doctor or pharmacist.
Your doctor will tell you what dose you should take. As the risk of side effects associated with heart problems may increase with dose and duration of use, it is important that you use the lowest dose that controls your pain and you should not take Celecoxib for longer than necessary to control symptoms.
Celecoxi b should b© SW3llOW©d who I© with 3 drink of W3tsr. The capsules can be taken at any time of the
day, with or without food. However, try to take each dose of Celecoxib at the same time each day.
Contact your doctor within two weeks of starting treatment if you do notexperience any benefit.
For osteoarthritis t
needed.
The dose is usually!
* one 200 mg capsule once a clay! or
* one 100 mg capsule twice a day.
For rheumatoid arthritis the usual dose is 200 mg each day, increased by your doctor to a maximum of 400 mg, if needed.
The dose is usually!
* one 100 mg capsule twice a day.
For ankylosing spondylitis the usual dose is 200 mg each day, increased by your doctor to a maximum of 400mg , if needed.
The dose is usually!
* one 200 mg capsule once a day! or
* one 100 mg capsule twice a day.
Kidney or liver problems! make sure your doctor knows if you have liver or kidney problems as you may
need a lower dose.
The elderly, especially those with a weight less than 50 kg:»you are over 65 years of age and especially
if you weigh less than 50 kg, your doctor may want to monitor you more closely.
You should not take more than 400 mg per day.
If you tske more Celecoxib thsn you should
You should not take more capsules than your doctor tells you to. If you take too many capsules contact your doctor, pharmacist or hospital and take your medicine with you.
If you forget to tske Celecoxib
If you forget to take a capsule, take it as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stoptsking Celecoxib
Suddenly stopping your treatment with Celecoxib may lead to your symptoms getting worse. Do not stop taking Celecoxib unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
the usual dose is 200 mg each day, increased by your doctor to a maximum
of 400 mg, if
The frequency of possible side effects listed below is defined using the following convention!
Very common! may affect more than 1 in 1 0 people Common! may affect up to 1 ,n 10 people Uncommon! may affect up to 1 in 100 people Rare! may affect up to 1 in 1000 people Very rare! may affect up to 1 in 10,000 people
No, known! frequency cannot be estimated from the available data
The side effects listed below were observed in arthritis patients who took Celecoxib. Side
(*\ (D
effects marked with an asterisk ^ ) are listed below at the higher frequencies that occurred in "O
patients who took Celecoxib to prevent colon polyps. Patientsin these studies took Celecoxib ^
at high doses and for a long duration. £
(0
sz
If any of the following happen, stop taking Celecoxiband tell your doctor immediately:
If you have
* an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing
* heart problems such as pain in the chest
* severe stomach pain or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained stools, or vomiting blood.
* a skin reaction such as rash, blistering or peeling of the skin
* liver failure (symptoms may include nausea (feeling sick), diarrhoea, jaundice (your skin or the whites of your eyes look yellow)).
Other side effects:
Very common
* High blood pressure.
Common
Heart attack
Fluid buildup with swollen ankles, legs and/or hands Infections of the urinary tract.
Shortness of breath , sinusitis (sinus inflammation, sinus infection, blocked or painful sinuses), blocked or runny nose, sore throat, coughs, colds, flu "like symptoms Dizziness, difficulty sleeping
Vomiting , stomach ache, diarrhoea, indigestion, wind Rash, itching Muscle stiffness Difficulty swallowing Worsening of existing allergies.
Uncommon
Stroke
Heart failure, palpitations (awareness of heart beat), fast heart rate Worsening of existing high blood pressure Abnormalities in liver'related blood tests Abnormalities in kidney "relate cl blood tests
Anaemia (changes in red blood cells thatcan cause fatigue and breathlessness)
Anxiety, depression, tiredness, drowsiness, tingling sensations (pins and needles)
High levels of potassium in blood test results (can cause nausea (feeling sick), fatigue, muscle weakness or palpitations)
Impaired or blurred vision, ringing in the ears, mouth pain and sores, difficulty hearing
Constipation, burping, stomach inflammation (indigestion, stomach ache or vomiting), worsening of inflammation of the stomach or intestine Leg cram ps
Raised itchy rash (hives).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Rsre
* Ulcers (bleeding) in the stomach, gullet or intestines! or rupture of the intestine (can cause stomach ache, fever, nausea, vomiting, intestinal blockage), dark or black stools, inflammation of the gullet (can cause difficulty in swallowing), inflammation of the pancreas (can lead to stomach pain)
* Reduced number of white blood cells (which help protect the body from infection) and blood platelets (increased chance of bleeding or bruising)
* Difficulty coordinating muscular movements
* Feeling confused, changes in the way things taste
* Increased sensitivity to light
* Loss of hair.
Not known: frequency esnnot be estimsted from the available dsts:
* Bleeding within the brain causing death
* Serious allergic reactions (including potentially fatal anaphylactic shock) which can cause skin rash, swelling of the face, lips, mouth, tongue or throat, wheezing or difficulty breathing! difficulty swallowing
* Bleeding of the stomach or intestines (can lead to bloody stools or vomiting), inflammation of the intestine or colon, nausea (feeling sick)
* Serious skin conditions such as Stevens'Johnson syndrome, exfoliative dermatitis and toxic epidermal necrolysis (can cause rash, blistering or peeling of the skin) and acute generalised exanthematous pustulosis (red swollen area with numerous small pustules)
* Liver failure, liver damage and severe liver inflammation (sometimes fatal or requiring liver transplant). Symptoms may include nausea (feeling sick), diarrhoea, jaundice (yellow discolouration of the skin or eyes), dark urine, pale stools, bleeding easily, itching or chills
Kidney problems (possible kidney failure, inflammation of the kidneys)
Blood clot in the blood vessels in the lungs. Symptoms may include sudden breathlessness, sharp pains when you breathe or collapse Irregular heartbeat
Meningitis (inflammation of the membrane around the brain and spinal cord)
Hallucinations
Worsening of epilepsy (possible more frequent and/or severe seizures)
Inflamed blood vessels (can cause fever, aches, purple blotches on the skin)
Blockage of an artery or vein in the eye leading to partial or complete loss of vision, inflammation of the conjunctiva, bleeding in the eye
A reduction in the number of red and white blood cells and platelets (may cause tiredness, easy bruising, frequent nose bleeds and increased risk of infections)
Chest pain
Impaired sense of smell
Skin discolouration (bruising), muscle pain and weakness, painful joints Menstrual disturbances Headache, flushing
Low levels of sodium in blood test results (can cause loss of appetite, headache, nausea (feeling sick), muscle cramps and weakness)